Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350974
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2006-07-10
Brief Title:
ADMA Levels in End-Stage Renal Disease
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Determination of Asymmetrical Dimethylarginine ADMA Accumulation in End Stage Renal Disease
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Asymmetric dimethylarginine ADMA in plasma is significantly elevated in patients with renal disease and associated with cardiovascular morbidity and mortality We found that whole blood WB possesses the metabolic pathways required for both the generation and elimination of ADMA and we have developed ex vivo methods to assess the WB accumulation of ADMA in humans The over-arching hypothesis is that dysregulation of ADMA metabolic pathways leads to greater ADMA whole blood content and greater capacity to accumulate ADMA which 1 is not reflected by plasma levels and 2 is a better predictor of cardiovascular outcome than plasma levels in end-stage renal disease ESRD The following specific aims will be pursued to characterize whole blood ADMA in ESRD
1 Compare and contrast baseline free plasma ADMA and total whole blood free plus protein-incorporated ADMA concentrations in ESRD patients matched hypertensive controls and a normal population
2 Determine the capacity of WB to accumulate the net balance of generation and elimination ADMA in ESRD patients matched hypertensive controls and a normal population
We will use state-of-the-art high performance liquid chromatography techniques to measure ADMA levels in plasma and whole blood Samples for ADMA measurements will be obtained from subjects with end-stage renal disease immediately before their dialysis treatments Samples will also be obtained from volunteers without kidney disease This group will be matched to the end-stage renal volunteers by age gender and ethnicity These volunteers will also be matched for the presence of hypertension and diabetes The third group will consist of a normal population to measure the normal levels of ADMA and compare to the other two groups
There is growing evidence to support a pathological role of ADMA in humans These experiments will enhance our understanding of how ADMA is processed in the human body and how it is associated with kidney disease Potentially these results will lay the groundwork for new insights into the link between ADMA and the high cardiovascular disease burden in patients with kidney disease
1 Compare and contrast baseline free plasma ADMA and total whole blood free plus protein-incorporated ADMA concentrations in ESRD patients matched hypertensive controls and a normal population
2 Determine the capacity of WB to accumulate the net balance of generation and elimination ADMA in ESRD patients matched hypertensive controls and a normal population
We will use state-of-the-art high performance liquid chromatography techniques to measure ADMA levels in plasma and whole blood Samples for ADMA measurements will be obtained from subjects with end-stage renal disease immediately before their dialysis treatments Samples will also be obtained from volunteers without kidney disease This group will be matched to the end-stage renal volunteers by age gender and ethnicity These volunteers will also be matched for the presence of hypertension and diabetes The third group will consist of a normal population to measure the normal levels of ADMA and compare to the other two groups
There is growing evidence to support a pathological role of ADMA in humans These experiments will enhance our understanding of how ADMA is processed in the human body and how it is associated with kidney disease Potentially these results will lay the groundwork for new insights into the link between ADMA and the high cardiovascular disease burden in patients with kidney disease
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None